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Cogent Biosciences, Inc. is a biotechnology firm dedicated to creating targeted treatments for illnesses rooted in specific genetic anomalies. The company's primary therapeutic candidate is CGT9486, a selective tyrosine kinase inhibitor engineered to block the KIT D816V mutation, a key driver of systemic mastocytosis, along with other KIT exon 17 mutations observed in individuals suffering from advanced gastrointestinal stromal tumors (GIST). Furthermore, Cogent holds a licensing pact with Plexxikon Inc., granting it rights for the investigation, advancement, and marketing of bezuclastinib…

Submission based on results of APEX pivotal trial which demonstrated bezuclastinib objective response rate (CR+CRh+PR+CI) of 65% per mIWG criteria and 81% ORR per PPR criteria with a well-tolerated safety profile for AdvSM patients

Cogent Biosciences is positioned to build a niche KIT-mutant franchise, leveraging bezuclastinib across three pivotal indications with strong clinical data. COGT holds $866.4 million in cash, supporting operations through 2028 and enabling launches in systemic mastocytosis and GIST, mitigating near-term financing risk. Bezuclastinib has demonstrated robust efficacy in nonadvanced and advanced systemic mastocytosis and second-line GIST, with three regulatory filings and positive pivotal trial results.

- JAK2 V671F poster presentation showcases potential best-in-class properties, including improved selectivity compared with currently approved JAK inhibitors -

-- Bezuclastinib demonstrated rapid and deep clinical benefit in AdvSM patients resulting in an updated objective response rate (CR+CRh+PR+CI) of 65% per mIWG criteria and 81% ORR per PPR criteria –

Bezuclastinib combination is first treatment ever to demonstrate statistically significant advantage against active comparator in GIST patients; median PFS of 16. 5 months versus 9. 2 months (HR=0. 50, CI: 0. 39-0.